FDA.reportPublic FDA data

truSculpt

Primary DI
00816722021403
Brand
truSculpt
Company
CUTERA, INC.
Model
truSculpt
Device description
truSculpt RF Device
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816722021403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816722021403008167220214038167220214030816722021403

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-415-657-5500info@cutera.com

Regulatory Flags#

DUNS number
041071643
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816722022158Pearl FractionalPearl Fractional2016-09-23
00816722022714AviClearAviClear Large handpiece2025-08-18
00816722022707AviClearAviClear2022-04-01
00816722021700AviClearAviClear2022-04-01
00816722021007CoolGlide CVCoolGlide CV2016-09-23
00816722021014CoolGlide ExcelCoolGlide Excel2016-09-23
00816722021021CoolGlide VantageCoolGlide Vantage2016-09-23
00816722021038CoolGlide GenesisCoolGlide Genesis2016-09-23
00816722021205Genesis PlusGenesis Plus2016-09-23
00816722021502excel HRexcel HR2016-09-23
00816722023209Genesis Plus 1 mm Spot Size AdapterGenesis Plus 1 mm Spot Size Adapter2016-09-23
00816722021410truSculpt truSculpt 2 MHz2017-03-21
00816722021427truSculpt iDtruSculpt iD2018-06-27
00816722022400truSculpt 16truSculpt 162016-09-19
00816722022417truSculpt 25truSculpt 252016-09-19
00816722022424truSculpt 40truSculpt 402016-09-19
00816722022431truSculpt 3DtruSculpt 3D2017-03-27
00816722022806AcutipAcutip2023-05-15
00816722021816xeo+ SAxeo+ SA2022-11-30
00816722022813Limelight Limelight 2022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810140063229Renpho RejuvenJoicom CorporationISA2026-10-20
08809932290075NeoSculpt PlusS&M Medical Inc.PBX2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDPBX2026-10-20
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDPBX2026-10-12
00810226442610ViveVIVE HEALTH LLCISA2026-10-09
00810226442627ViveVIVE HEALTH LLCISA2026-10-09
00810226442634ViveVIVE HEALTH LLCISA2026-10-09
00810226442641ViveVIVE HEALTH LLCISA2026-10-09
08809932290082NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290099NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290112NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
00872320007218SveltivaCAO GROUP, INC.PBX2026-10-01
00850018480888Primo PassiPrimo Passi LLCISA2026-09-21
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
08032625821120GLOBUSDOMINO SRLPBX2026-09-19
06977444420005Shuhai JingweiShuhai Jingwei (Shenzhen) Information Technology Co., Ltd.ISA2026-09-04
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDPBX2026-08-26
08800250281332QuadtheraECO DM LAB Co., Ltd.ISA2026-08-21
00817915020296Etekcity Smart Fitness ScaleVesync (US) CorporationISA2026-08-14
088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29